A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease

Cullinan Therapeutics Inc.

Status and phase: Enrolling; Phase 1

Conditions: Sjogren's Syndrome; Sjögren; Sjogren Disease

Treatments: Drug: CLN-978

Study type: Interventional

Funder types: Industry

Identifiers

NCT07041099

CLN-978-SJ-101

Details and patient eligibility

About

A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.

• Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.

• Laboratory parameters including the following:

  • Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L
  • Peripheral CD19+ B cell count ≥25 cells/µL
  • Absolute neutrophil count (ANC) ≥1.0 × 10^9/L
  • Hemoglobin (Hgb) ≥8 g/dL
  • Platelet count ≥75 × 10^9/L
  • Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN
  • Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2

Exclusion

• Concomitant rheumatological autoimmune disease
• Considered at high risk for thrombosis
• Rapidly progressive glomerulonephritis and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
• Active, severe central nervous system manifestations of SjD.
• History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.
• Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
• Primary immunodeficiency or history of recurrent infections.
• History of splenectomy.
• Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.
• Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.
• Active or latent tuberculosis (TB)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Part A Dose Escalation

Experimental group

Description:

Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts

Treatment:

Drug: CLN-978

Part B Further Dose Evaluation

Experimental group

Description:

Further evaluation of CLN-978 treatment of patients with Sjogren's Disease

Treatment:

Drug: CLN-978